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Clinical trial

Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis From Breast Cancer

ID
Name
Exo-LCR
Description
The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis.
Trial arms
Trial start
2023-01-04
Estimated PCD
2025-12-01
Trial end
2026-12-01
Status
Recruiting
Treatment
Consultation
History of the disease, anatomopathological and molecular biological data concerning the initial tumor; Collection of treatments received and/or in progress by the patient for her meningeal tumor (chemotherapy, targeted therapy, radiotherapy, surgery, corticosteroids, antiepileptics); Evaluation of the general condition and neurological status.
Arms:
Study process
Cerebral and medullary MRI, lumbar puncture, CSF sampling
diagnosis of leptomeningeal involvement
Arms:
Study process
biological test
5 ml of additional CSF after diagnostic lumbar puncture for proteomic analysis, 50-100 µl of breast aspiration fluid (NAF) for patients with an existing breast tumor, for proteomic analysis 10 ml of blood for proteomic analysis
Arms:
Study process
Size
30
Primary endpoint
CSF protein composition
36 months
cytological analysis of the CSF
36 months
Eligibility criteria
Inclusion Criteria: * Patient with histologically proven breast cancer; * Patient with suspected metastatic leptomeningeal involvement; * Age ≥ 18 ans ; * WHO performance status ≤ 2 ; * Affiliation to the National Social Security System ; * With informed and signed consent Exclusion Criteria: * History of another cancer than the one for which the patient is referred; * Contraindication to lumbar puncture or cerebrospinal MRI * Pregnant or breastfeeding woman
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2024-05-30

1 organization

1 product

1 indication

Organization
Centre Oscar Lambret
Product
Biological test
Indication
Breast Cancer